I am posting this week’s regulatory update a day early since our office will be closed tomorrow for the holiday weekend. Only one new molecular entity was approved this week, along with a couple of new indication approvals. The FDA approved Kevzara (sarilumab), a treatment of rheumatoid arthritis which was co-developed by Sanofi and Regeneron. […]
There has been a lot of big news in the industry this week and here are some of the key regulatory highlights: The U.S. Senate confirmed Dr. Scott Gottlieb as the next commissioner of the FDA. Gottlieb, 44, served as an FDA deputy commissioner during the George W. Bush administration. He has also worked as a[…]
This has been another exciting week with a flurry of regulatory activity in pharma and biotech. The FDA approved Radius Health’s drug TYMLOS to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies. However, this included a “black box” warning that the treatment had increased the[…]
